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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glucose dehydrogenase, glucose
Product CodeLFR
Regulation Number 862.1345
Device Class 2

MDR Year MDR Reports MDR Events
2020 132 132
2021 164 164
2022 101 101
2023 103 103
2024 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 211 211
Incorrect, Inadequate or Imprecise Result or Readings 207 207
Non Reproducible Results 107 107
Low Test Results 76 76
Erratic Results 48 48
Material Twisted/Bent 7 7
Incorrect Measurement 6 6
Unintended Movement 5 5
Component Missing 5 5
Inaccurate Information 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Circuit Failure 3 3
Loss of or Failure to Bond 3 3
Output Problem 3 3
Device Displays Incorrect Message 3 3
No Apparent Adverse Event 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Shipping Damage or Problem 3 3
Display or Visual Feedback Problem 2 2
Illegible Information 2 2
Failure to Fire 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Failure to Power Up 2 2
Material Integrity Problem 2 2
Incomplete or Missing Packaging 2 2
Activation, Positioning or Separation Problem 2 2
Use of Device Problem 1 1
Imprecision 1 1
Device Difficult to Program or Calibrate 1 1
High Readings 1 1
Calibration Problem 1 1
Product Quality Problem 1 1
Low Readings 1 1
Defective Component 1 1
Failure to Sense 1 1
Insufficient Information 1 1
Device Markings/Labelling Problem 1 1
Image Display Error/Artifact 1 1
Display Difficult to Read 1 1
No Device Output 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 451 451
No Consequences Or Impact To Patient 167 167
Hyperglycemia 19 19
Hypoglycemia 12 12
Insufficient Information 9 9
Diabetic Ketoacidosis 3 3
Vomiting 3 3
Coma 3 3
Shaking/Tremors 3 3
No Known Impact Or Consequence To Patient 2 2
Loss of consciousness 2 2
Abdominal Pain 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fatigue 1 1
Skin Irritation 1 1
Confusion/ Disorientation 1 1
Tachycardia 1 1
Aphonia 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diabetes Care, Inc. II Aug-26-2021
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